How to Design and Implement Powder-to-Tablet Continuous Manufacturing Systems provides a comprehensive overview on the considerations necessary for the design of continuous pharmaceutical manufacturing processes. The book covers both the theory and design of continuous processing of associated unit operations, along with their characterization and control. In addition, it discusses practical insights and strategies that the editor and chapter authors have learned. Chapters cover Process Analytical Technology (PAT) tools and the application of PAT data to enable distributed process control.
With numerous case studies throughout, this valuable guide is ideal for those engaged in, or learning about, continuous processing in pharmaceutical manufacturing.
1. Chapter 1. Introduction - p. 1 2. Chapter 2. Characterization of material properties - p. 9 3. Chapter 3. Loss-in-weight feeding - p. 29 4. Chapter 4. Continuous powder mixing and lubrication - p. 59 5. Chapter 5. Continuous dry granulation - p. 93 6. Chapter 6. A modeling, control, sensing, and experimental overview of continuous wet granulation - p. 119 7. Chapter 7. Continuous fluid bed processing - p. 141 8. Chapter 8. Continuous tableting - p. 159 9. Chapter 9. Continuous film coating within continuous oral solid dose manufacturing - p. 179 10. Chapter 10. Role of process analytical technology in continuous manufacturing - p. 201 11. Chapter 11. Developing process models of an open-loop integrated system - p. 229 12. Chapter 12. Integrated process control - p. 251 13. Chapter 13. Applications of optimization in the pharmaceutical process development - p. 271 14. Chapter 14. Regulatory considerations for continuous solid oral dose pharmaceutical manufacturing - p. 301 15. Chapter 15. Continuous manufacturing process development case study - p. 319 16. Chapter 16. Orkambi: a continuous manufacturing approach to process development at Vertex - p. 383 17. Chapter 17. Outlook—what comes next in continuous manufacturing (and in advanced pharmaceutical manufacturing) - p. 397 18. Index - p. 401
How to Design and Implement Powder-to-Tablet Continuous Manufacturing Systems provides a comprehensive overview on the considerations necessary for the design of continuous pharmaceutical manufacturing processes. The book covers both the theory and design of continuous processing of associated unit operations, along with their characterization and control. In addition, it discusses practical insights and strategies that the editor and chapter authors have learned. Chapters cover Process Analytical Technology (PAT) tools and the application of PAT data to enable distributed process control.
With numerous case studies throughout, this valuable guide is ideal for those engaged in, or learning about, continuous processing in pharmaceutical manufacturing.
1. Chapter 1. Introduction - p. 1 2. Chapter 2. Characterization of material properties - p. 9 3. Chapter 3. Loss-in-weight feeding - p. 29 4. Chapter 4. Continuous powder mixing and lubrication - p. 59 5. Chapter 5. Continuous dry granulation - p. 93 6. Chapter 6. A modeling, control, sensing, and experimental overview of continuous wet granulation - p. 119 7. Chapter 7. Continuous fluid bed processing - p. 141 8. Chapter 8. Continuous tableting - p. 159 9. Chapter 9. Continuous film coating within continuous oral solid dose manufacturing - p. 179 10. Chapter 10. Role of process analytical technology in continuous manufacturing - p. 201 11. Chapter 11. Developing process models of an open-loop integrated system - p. 229 12. Chapter 12. Integrated process control - p. 251 13. Chapter 13. Applications of optimization in the pharmaceutical process development - p. 271 14. Chapter 14. Regulatory considerations for continuous solid oral dose pharmaceutical manufacturing - p. 301 15. Chapter 15. Continuous manufacturing process development case study - p. 319 16. Chapter 16. Orkambi: a continuous manufacturing approach to process development at Vertex - p. 383 17. Chapter 17. Outlook—what comes next in continuous manufacturing (and in advanced pharmaceutical manufacturing) - p. 397 18. Index - p. 401
